ISO INTERNATIONAL STANDARD 15223-2 First edition 2010-01-15 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation Dispositifs medicaux Symboles a utiliser avec les étiquettes I'étiquetage et les informations a fournir relatifs aux dispositifs medicaux- Partie 2: Développement, sélection et validation de symboles Reference number ISO 15223-2:2010(E) @ ISO 2010 ISO 15223-2:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF fle can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below COPYRIGHTPROTECTEDDOCUMENT @ISO2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, IsO's member body in the country of the requester. ISO copyright office Case postale 56 . CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland ii @ ISO 2010 - All rights reserved ISO 15223-2:2010(E) Contents Page Foreword Introduction. 1 Scope. 2 Normative references.. 3 Terms and definitions . 4 Principles for identification and development of new symbols . 4.1 Identifying the need for a symbol.. 4.2 Symbols with horizontal applications .... 4.3 Symbols for use within a restricted range of device types. 5 Process for selecting and validating symbols for inclusion in Iso 15223-1... 5.1 5.2 Initialevaluation 5.3 Second evaluation, 6 Classification of risk ... 7 Concept development... 7.1 Existence of other symbols. 7.2 Symbol design .... 8 Evaluation.... 8.1 Testing early symbol concepts 8.2 Comprehension testing . 8.3 Memory testing .. 8.4 Usability testing.. 9 Acceptance criteria .. 10 9.1 10 9.2 Symbols with no to low safety relevance ... 10 9.3 Symbols with moderate to high safety relevance.... 10 Annex A (normative) Information to be provided during the symbol development process for adoption of a symbol into Iso 15223-1... 11 Annex B (normative) IsO/Tc 145/Sc 3 proposal for graphical symbols.. 12 Annex C (normative) IEC/Sc 3C proposal for graphical symbol form 14 Bibliography... 16 @IsO2010-All rights reserved ii